Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01875679
Other study ID # CSC2013
Secondary ID
Status Completed
Phase N/A
First received May 15, 2013
Last updated May 19, 2015
Start date May 2013
Est. completion date October 2014

Study information

Verified date May 2015
Source St. Michael's Hospital, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

Simulation in surgical skills training is widely accepted as a necessary step to improve surgical training outside the operating room. Simulation predominately focuses on teaching a specific task or procedure. Once this task is acquired ongoing optimization of technique is desirable. Commonly ongoing skills assessment occurs in the form of peer feedback throughout training rotations. This feedback is frequently subjective and of variable educational use. Identifying ongoing technical training needs and enabling personalized objective feedback represents an important training concept that has not yet been formally used in resident training.

The specific goal of this study is to prove the effect of a comprehensive surgical coaching (CSC) approach which combines concepts of behavior modeling training, task debriefing and error recognition to improve overall surgical technique without additional technical skills training.


Description:

Design The study design is a randomized, controlled trial involving evaluation of a study and a conventionally trained group at pretest and posttest.

Participants The study and control groups will consist of senior surgical residents (PGY 3-5) and surgical fellows involved in minimally invasive surgery (MIS).

Inclusion: Since concurrent operative training in the operating room (OR) in the technique of MIS is a prerequisite for this study, only residents and fellows on rotations with a practice focus on MIS during the time period of the study will be eligible for participation.

Exclusion: Individuals with severe illnesses precluding performance in the OR will not be included.

Outcome measures: Surgical performance will be assessed using a global rating scale as well as through tabulation of observed intraoperative technical errors. Primary outcome measure is surgical skill level before and after targeted training.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- surgical residents and fellows on rotations with a practice focus on minimally invasive surgery during the time period of the study

Exclusion Criteria:

- individuals with severe illnesses precluding performance in the OR

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)


Related Conditions & MeSH terms


Intervention

Other:
Comprehensive Surgical Coaching

Conventional Surgical Training
Surgical training as per participant's residency program

Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surgical Technical Skill Surgical skill measures as recorded on a procedure specific global rating scale, Objective Structured Assessment of Technical Skills (OSATS) and bariatric OSATS (BOSATS) scores and by tabulation of technical errors, Generic Error Rating Tool (GERT) observed during the index procedures. After 8 weeks of participation No
Secondary Learning curves Development of skill and reduction of errors will be assessed in relation to number of procedures performed to obtain learning curves for each study group.
Surgical technical skill will be assessed by OSATS and BOSATS scales, errors will be recorded by GERT checklist
Throughout 8 weeks of participation No